AEQUALIS™ FLEX REVIVE™ ARS342007Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
All models of AEQUALIS FLEX REVIVE (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846832069347), received between Jul 29, 2025 and Jul 29, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Biocompatibility” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Biocompatibility1
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration1
- Metal Related Pathology1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2025Loss of Osseointegration; Biocompatibility; Loss of Osseointegration; Biocompatibility
A REVISION SURGERY WAS REQUIRED FOLLOWING THE DISENGAGEMENT OF THE TRAY FROM THE REVIVE STEM IN AN ACTIVE, INDEPENDENTLY MOBILE PATIENT WHO PRESENTED WITH ACUTE SHOULDER PAIN. INTRAOPERATIVE FINDINGS REVEALED A LOOSE STEM, FAILURE AT THE MORSE TAPER INTERFACE, PSEUDOMEMBRANE FORMATION AROUND THE TRAY, AND SIGNIFICANT METALLOSIS. THE STEM, TRAY, AND LINER WERE REVISED USING A LARGER STEM SIZE, WHILE THE GLENOSPHERE AND SCREWS REMAINED INTACT DUE TO STABLE FIXATION. POSTOPERATIVELY, THE PATIENT UNDERWENT STANDARD REHABILITATION, INCLUDING SLING IMMOBILIZATION FOR 3 TO 4 WEEKS FOLLOWED BY GENTLE MOBILIZATION UNDER PHYSIOTHERAPY SUPERVISION. X-RAY IMAGES ARE NOT INCLUDED DUE TO PATIENT CONFIDENTIALITY.
Patient problems: Inadequate Osseointegration; Metal Related Pathology; Pain
MAUDE report 22649365 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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